Analgesic efficacy and safety of ketorolac after photorefractive keratectomy. Ketorolac Study Group.

PURPOSE The analgesic efficacy and safety of topical ketorolac tromethamine 0.5% ophthalmic solution (Acular) in photorefractive keratectomy was compared to its vehicle. METHODS Double-masked, multicenter, study of 200 patients dosed with 1 drop of study medication (ketorolac or vehicle) in the operated eye immediately after surgery (eye patched), with four-times daily dosing for the next 3 days starting 3 hours after surgery. Mepergan Fortis was available as an escape pain medication. RESULTS Patients (102) in the ketorolac group reported significantly greater pain relief and less pain intensity than the vehicle group (98) at several time points (P < or = .039). Time to first use of escape medication was significantly longer in the ketorolac than the vehicle group (mean, 16.0 vs 5.5 hr; P =.001). Time to complete pain relief was significantly shorter in the ketorolac than the vehicle group (mean, 41.3 vs 50.3 hr; P =.022). Significantly fewer patients in the ketorolac group reported sleep difficulties, ocular discomfort, or other difficulties. Few adverse events were reported with ketorolac treatment (less than with vehicle), and there were no clinically significant changes in any of the safety variables monitored. CONCLUSIONS Ketorolac tromethamine 0.5% ophthalmic solution (Acular) is safe and significantly more effective than vehicle in alleviating pain following photorefractive keratectomy.